22 MARKET NEWS

First approval for tacroIimus imminent Fujisawa expect that their immunosuppressant,

tacrolimus [FK 506; PrograP), will shortly be approved in Japan for liver transplantation. This follows a recommendation for approval from the Central Pharmaceutical Affairs Council. The Council classified tacrolimus as an 'innovative new drug', although its mode of action appears to resemble that of the standard immunosuppressant, cyclosporin. This classification may allow Fujisawa to command a price premium. However, liver transplantation is a small market with only 30-40 cases per year.

A launch is expected soon after price negotiations, which should be completed by May. Japan will be the first worldwide market for tacrolimus. It is expected that an NDA will be submitted to the FDA in May, and applications will be made in the UK, France and Germany later in the year.

Clinical trials of tacrolimus in kidney trans- . plantation are in phase III in Japan and in phase n in the US. Tacrolimus is also being investigated for bone marrow transplantation, psoriasis, multiple sclerosis and uveitis associated with Beh~et's disease.

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